MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "LF-GP", SET E; TRACHEAL INTUBATION FIBERSCOPE

Model Number	LF-GP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2429304-2022-00004.
Event or Problem Description
The customer reports during an unspecified thoracic procedure using a lf-gp fiberscope, had a piece of the insertion tube break off into the patient's larynx during a procedure and had to be retrieved.The intended procedure was completed.No further consequences to the patient have been reported.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.The device was returned to olympus for evaluation.The insertion portion was inspected under a microscope and found approximately 50 percent of the bend section cover glue was detached on the insertion tube side.The missing portion was returned with the physical device.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.Device history record (dhr) review: olympus confirmed via dhr that the subject device was shipped in accordance with all design and safety specifications.Labeling review.Users can detect/prevent the reported event properly by handling the device in accordance with the following instructions for use (ifu).·preparation and inspection ¿ preparation and inspection of the endoscope ¿ visually inspect the surface of the insertion tube for dents, bulges, swelling, peeling or other irregularities.·important information ¿ please read before use ¿ warnings and cautions ¿ do not strike the distal end of the insertion tube or allow it to strike other objects.The objective lens surface of the distal end is particularly fragile, and vision abnormalities may result.Do not twist or bend the bending section by hands.Equipment damage may result.Do not squeeze the bending section forcefully.The bending section¿s covering may stretch or break and cause water leaks.The definitive cause of the reported event could not be determined.Presumable cause: the device has been damaged by physical stress during user handling for a long period.A part of insertion section was broken and came off in the patient¿s airway because the device in that state was used for procedure.

• Brand Name: FIBERSCOPE "LF-GP", SET E
• Common Device Name: TRACHEAL INTUBATION FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; tokyo-to, hachioji-shi 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 15095585
• Report Number: 8010047-2022-12106
• Device Sequence Number: 17442408
• Product Code: EOQ
• UDI-Device Identifier: 03701354402003
• UDI-Public: 03701354402003
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K981543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LF-GP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown